MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

Catalog Number	STK-AT-012
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Hypoglycemic Shock (4575)
Date of Event	05/18/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).H6 health effect - clinical code - e0115 encephalopathy.
Event or Problem Description
It was reported via maude report number mw5174584 that an alert/notification settings issue occurred.The relationship of the reporter to the patient was not provided.According to the report, the patient used g7 receiver and was found unresponsive on (b)(6) 2025.She was airlifted to a hospital.She had suffered seizures from hypoglycemic shock and reportedly did not recover from the resulting brain damaged and died sometime later.Before her death, she underwent testing which showed ongoing seizures.According to the report, her glucose was under 40 mg/dl for 13 hours by the time of her discovery.The cause of death was reported to be metabolic encephalopathy due to hypoglycemia.After her death, a letter from dexcom was received notifying about the receiver alert problem.The report notes that the patient lived alone and depended on glucose alerts from the receiver.Attempts to contact the reporter for additional details by phone were unsuccessful.No product or data was provided for investigation.A return goods kit has been sent to the patient¿s family to return the alleged receiver for investigation.A follow up report will be submitted upon device investigation completion if the device is returned.No additional patient or event information is available.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the initial mdr, additional information is required.

• Brand Name: DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 23137581
• Report Number: 3004753838-2025-269710
• Device Sequence Number: 9117845
• Product Code: QBJ
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K213919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: STK-AT-012
• Device Lot Number: 17703174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 69 YR
• Patient Sex: Female